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Oral Glyceryl Triacetate (GTA) in Newborns With Canavan

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Disease Information

Descriptive Information
Brief Title † Oral Glyceryl Triacetate (GTA) in Newborns With Canavan
Official Title † Oral Glyceryl Triacetate (GTA) in Newborns With Canavan
Brief Summary Canavan disease is caused by Aspartoacylase deficiency. There is no treatment for the disease, but there is a food additive that includes acetate . We suggest an early treatment with acetate and a neurologic evaluation, including MRI, after 4 months of treatment. In any case the treatment will be stopped at the age of 22 months, when myelinization is ended.
Detailed Description
Study Phase N/A
Study Type † Interventional
Study Design † Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary Outcome Measure † brain MRI at the end of the study
Secondary Outcome Measure †
Condition † Canavan Disease
Intervention † Dietary SupplementGTA (Glyceryl triacetate)
Study Arms / Comparison Groups
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Dietary Supplement
Estimated Enrollment † 1
Start Date † March 2008
Completion Date
Primary Completion Date August 2008
Eligibility Criteria † Inclusion Criteria: - clinical diagnosis of Canavan disease Exclusion Criteria: - Age above 18 months
Gender Both
Ages N/A - 18 Months
Accepts Healthy Volunteers No
Contacts †† Gheona Alterescu, MD, 972-2-6666435, gheona@szmc.org.il
Location Countries † Israel
Administrative Information
NCT ID † NCT00724802
Organization ID canavangta
Secondary IDs ††
Responsible Party
Study Sponsor † Shaare Zedek Medical Center
Collaborators ††
Investigators † Principal Investigator: Gheona Alterescu, M.D., Shaare Zedek Medical Center
Information Provided By
Verification Date June 2011
First Received Date † June 18, 2008
Last Updated Date June 20, 2011
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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